NDC 63187-513

ondansetron

Ondansetron Hydrochloride

ondansetron is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Ondansetron Hydrochloride.

Product ID63187-513_48ce80a1-5af3-465e-96d9-ef192cafafe3
NDC63187-513
Product TypeHuman Prescription Drug
Proprietary Nameondansetron
Generic NameOndansetron Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-06-25
Marketing CategoryANDA / ANDA
Application NumberANDA077851
Labeler NameProficient Rx LP
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63187-513-10

10 TABLET, FILM COATED in 1 BOTTLE (63187-513-10)
Marketing Start Date2018-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-513-10 [63187051310]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-01

NDC 63187-513-20 [63187051320]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 63187-513-15 [63187051315]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 63187-513-30 [63187051330]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-01

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:bde7c22c-0047-4735-8df6-b48e8dfa478a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312086

    • Pharmacological Class

    • Serotonin 3 Receptor Antagonists [MoA]
    • Serotonin-3 Receptor Antagonist [EPC]
    • Serotonin 3 Receptor Antagonists [MoA]
    • Serotonin-3 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "ondansetron" or generic name "Ondansetron Hydrochloride"

    NDCBrand NameGeneric Name
    0143-2422OndansetronOndansetron hydrochloride
    0143-2423OndansetronOndansetron hydrochloride
    0143-2424OndansetronOndansetron
    0143-9890OndansetronOndansetron
    0143-9891OndansetronOndansetron
    0179-0099ondansetronondansetron hydrochloride
    0179-0100ondansetronondansetron hydrochloride
    0378-0315Ondansetronondansetron
    0378-0344Ondansetronondansetron
    0378-0374Ondansetronondansetron
    0378-7732OndansetronOndansetron
    0378-7734OndansetronOndansetron
    0404-9930ONDANSETRONONDANSETRON
    67877-169ondansetronondansetron
    67877-170ondansetronondansetron
    0409-4755OndansetronOndansetron
    0409-4759OndansetronOndansetron
    68001-247OndansetronOndansetron
    68001-246OndansetronOndansetron
    68071-1547OndansetronOndansetron
    68071-1804OndansetronOndansetron
    68071-1658OndansetronOndansetron
    68071-1730OndansetronOndansetron
    68071-1904OndansetronOndansetron
    68071-1649OndansetronOndansetron
    68071-1987OndansetronOndansetron
    68071-1968ONDANSETRONONDANSETRON
    68071-1977ONDANSETRONONDANSETRON
    68071-3028OndansetronOndansetron
    68071-3195OndansetronOndansetron
    68071-3268OndansetronOndansetron
    68071-4190OndansetronOndansetron
    68071-3275OndansetronOndansetron
    68071-4191ONDANSETRONONDANSETRON
    68071-4513OndansetronOndansetron
    68071-4426OndansetronOndansetron
    68071-4115OndansetronOndansetron
    68071-4566OndansetronOndansetron
    68071-4570OndansetronOndansetron
    68071-4409OndansetronOndansetron
    68071-4594OndansetronOndansetron
    68071-4810OndansetronOndansetron
    68071-4717OndansetronOndansetron
    68083-114OndansetronOndansetron
    68083-113OndansetronOndansetron
    68071-4529ondansetronondansetron
    68258-7068OndansetronOndansetron
    68462-105OndansetronOndansetron
    68462-157OndansetronOndansetron
    68462-158OndansetronOndansetron
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